Prescribing brand-name drugs when generic drugs are available generates unnecessary medical expenditures, the costs of which are borne by the public in the form of higher copayments, increased health insurance costs, and higher Medicare and Medicaid expenses. Pharmaceutical companies aim to stimulate patients’ requests for brand-name medications and increase the likelihood physicians will honor such requests. Presently, little is known about how frequently physicians comply with such a request or the factors predicting this behavior.

This was a national survey of 1891 physicians in 7 specialties asking why they prescribed name brand alternatives over generics. Here’s what they found:

The multivariable regression shows that 43% of physicians in practice more than 30 years sometimes or often give in to patients’ demands for brand-name drugs compared with 31% physicians in practice for 10 years or less (P = .001)…

Two specific forms of industry relationships were associated with significant differences in the percentage of physicians who acquiesced to patient demands. More than a third who received free food and/or beverages in the workplace honored patient requests sometimes or often compared with those who had not received food and beverages (39% vs 33%; P = .003). Similar significant differences were found among those receiving drug samples (40% vs 31%; P = .005). Also, physicians who sometimes or often met with industry representatives to stay up to date were significantly more likely to comply with patients’ demands than those who did not (40% vs 34%;P = .007).

Industry practices exist for a reason; it’s cause they work. Many physicians discount the free food at lunches as harmless, but such lunches are associated with prescribing name brand drugs. So are receiving free samples and meeting with representatives. Ignoring this evidence is fooling ourselves.

Once again, this is an easy way to save money, with almost no implications in terms of quality. I think it’s fine to spend your own money to get name brand drugs over generic equivalents. It’s hard to justify spending other people’s money for the privilege.

Docs have no incentive to say no and the practice is not harmful to the patient. perhaps they should confirm the patients understaNding of any increased co-pay and express an opinion as to the lack of value, but otherwise they are not the logical control point.

Interesting that the article implies that patients are demanding brand name drugs yet the onus seems to be on the physician to tell them no. If a patient needs a nasal steroid and they want the brand name instead of the generic, why would a physician tell them no? Better pricing (copays) of name brand drugs by third party payers seem to be a better approach in this instance.

With respect to free food, if it didn’t increase sales then it wouldn’t be available.

But there is the disturbing fact that on occasion, the generic drug does not behave identically like the original branded version. One specific case with which I have had a personal experience is the generic version of Singulair (montelucast sodium) immediately caused diarrhea and auditory hallucinations — before discovering that many other patients had similar symptoms. Things like this tend to make people a bit gunshy about other generics.

I completely agree that we need to cut costs. However, I have many anecdotes in my practice– not just from brand name to generic, but from different brands of generic–which were effectively blind in that the patient didn’t know until I called the pharmacy– that some generics in some patients are not equivalent. That being said, I always prescribe generics first, but if there is no response, I will absolutely switch to a brand name, since that is much cheaper than a hospitalization.

To be absolutely clear, I’m 100 percent for generics. But, The Merck manual, below, gives some examples where it might not be appropriate to use the generic. Drugs that must be given in very precise amounts, drugs for which a small difference in the bloodstream concentration makes a large therapeutic difference, cases where there’s an allergy to one of the inactive ingredients in the drug, all warrant caution. Or, oddly to me, there are a handful of generics that are not bioequivalent to the branded versions (apparently chlorpromazine, a typical antipsychotic and amitriptyline, a tricyclic antidepressant, are examples).

The FDA considers products to be bioequivalent if the peak blood drug concentration for the generic is close enough to the peak blood concentration for the branded (usually 80 to 125 percent for most drugs). From what I remember hearing in a lecture, the active chemical in the generic is the same as the one in the branded, but the fillers may be different. The formulation of the coating that enables time release might be different, for example.

Either way, it shouldn’t make a difference for most people. But it will for some. It’s reasonable, I think, for insurers to require a patient to fail on a generic where one is available. Of course, failure can be hard to assess. I have a relative who tried switching from a branded antidepressant to a generic version and reported failing. Was the failure due to non-bioequivalence, was it due to stress at the time, was it due to the placebo effect… either way, this relative is now on a branded-only antidepressant that her stupid insurance carrier charges a heck of a lot for.

Keep in mind that drugs aren’t my specialty. I’m not an MD, so I can’t speak to the accuracy of the Merck manual.

I am not saying that there are not anecdotes. But those happen to name-brand drugs, too. There are bad batches or problems every once in a while. But you can’t just rule out “generics” for that reason.

I’ve known a number of women who’ve had problems with different types of generic tamoxifen. They do just fine taking it for years and then get a refill from a different manufacture and suddenly have a whole body rash.

In some very rare cases it is possible that a patient is allergic to a particular excipient or dye, etc. used in a generic formulation, but the drug itself is still virtually the same if it is an A-rated substitute. And the possibility of issues with excipient allergies, etc. isn’t a point against generics considering that it is quite possible a patient is allergic to an excipient or dye used in a brand name drug, but is not allergic to the A-rated generic that does not contain that excipient.

Massachusetts just relaxed our gift ban rules to allow drug companies to buy food and drink for doctors again. Today’s Globe has a story on how happy restaurants are with the change. The triumph of politics over evidence-based policy.

This is such an important topic–big pharma has such a hold on the political class that any substantial reform is going to have to come from MDs themselves. If MDs simply used generics as much as possible this would significantly undercut the industry. Is there any hope for this? My understanding was that the ACA included some provisions to try to cut down on drug marketing.

Excellus BCBS in western/central NY mounted a major campaign to increase use of generics a few years ago.

In 2009, Excellus reported, “From October 2007 to October 2008, the overall ‘generic fill rate’ across 39 upstate New York counties increased by 4.5 percentage points, from 63.9 percent to 68.4 percent. This increase represents realized savings totaling approximately $369 million. Since October 2005, increases in upstate New York’s generic fill rate have resulted in savings totaling more than $725 million…”

The ‘generic fill rate’ was as high as 73% in one of the NY regions where Excellus operates, according to the company’s data.

I’ll accept the authors’ conclusion that the differences are statistically significant, but frankly I am not sure that they are practically significant. Yes, 39% is more than 33%, but either way it is roughly a third of doctors who give in to patients’ requests.

I worked a lot on studies to show equivalence of drug formulations. Frankly, it is sometimes nearly impossible to prove that one batch of a branded drug is equivalent to another batch of the same product, let alone proving equivalence between different formulations.

I would be particularly careful with drugs that have modified-release characteristics. It is extremely difficult to ensure equivalency between manufacturers in these cases.

Years ago, one could confidently assume that quality control was better in branded drugs vs. generics. Unfortunately, the major pharma companies seem to have dropped down to the level of the generics.

The percentage of prescriptions filled by generics is at it’s highest point ever and continues to climb. Even if it were 100% the impact would do little to the tremendous burden that overall healthcare costs are placing on the budgets of payers. (Govt, Employers & Consumers) The true cost comes from the management of chronic disease which accounts for roughly 75% of healthcare expenditures. In the end, prescriptions are a small % of the overall costs so any “savings” will be short-term and actually harmful in the long run. That is unless the generic manufacturers started reinvesting in R&D of future therapies.

Yes you can ban all pharmaceutical marketing to doctors but thats a very inefficient way to block this.

I think the best way to fight it is already being done — I dont know of a SINGLE insurance company that covers all drugs at 100%. If you choose a brand name, you are going to have a higher copay.

Now maybe those copays arent aggressive enough, but the framework is already in place. If an insurance company requires you to pay 100% of cost for a “brand” name drug, then you have fixed the problem. Even if a large percentage of patients choose to pay out of pocket for the brand name drug, thats fine because the cost is not spread to other insurance holders.

Just make the patient pay a 100% copay for all “brand” name drugs. Problem solved. The patients will quickly call the doctor back to get a cheap generic when they figure out that they are going to have to pay $320 for a brand name when there’s a cheaper generic for $40, which the insurance covers at 100% so the cost to the patient is really zero.

Consumer directed price consciousness doesnt work often in healthcare, but this is one example where it will SOLVE the problem easily.

When a drug goes off patent, it means the “recipe” to make that drug is now available for generic companies to manufacture and sell the drug. They may follow the recipe to the letter but there will potentially be differences in the final product because the source of the ingredients will not always be identical to what the brand manufacturer used. It would be like you getting the recipe for Oreo cookies. You could try to make them yourself but if you don’t use ingredients from the exact same sources that Nabisco uses, the end result will likely not taste the same even though you call the cookie an “Oreo”. Lastly, generic companies are not required to prove in a large, randomized, blinded study that their generic version is equivalent to the brand drug. So you are not likely to get the hard evidence you are asking for to prove a generic drug is inferior to a brand drug.

That’s just not the same. You eat a cookie for the recipe. You take a drug for the active ingredient. They don’t need to do a randomized controlled trial each time they make a tablet versus a pill versus a capsule to prove the drug works.

Aaron, the “active ingredient” is a chemical which needs to be synthesized. It is the individual reagents (eg. sodium, sulfur, iron, H2O, etc) that are mixed together to synthesize the active compound which can differ if they are obtained from different sources. The differences are most likely to be in purity. Often this makes no difference in the activity of the final product, but occasionally it can. And even though the FDA tests generics for equivalent strength, purity, etc they do allow some variation from the brand name drug and do not require “spot on” identical specs. I just wanted to make the point that there could be a legitimate biological reason why a patient responds better to a brand name drug vs the generic version. It’s not just “all in their head” or because the doctor ate a sandwich provided by a drug rep.

Just because there can be something wrong is not a reason to say there is. There are – what – billions of generic pills out there? Show me data that illustrate their danger on a measurable, clinically significant scale.

You will never get this measurable “clinically signifcant” data without doing a double blind randomized clinical trial that measures multiple endpoints including activity against the disease (not just a few blood draws and PK timepoint measurments) because no generic company is going to spend the money to do the study. If they did, the price of the generic would skyrocket. In the abscence of that, all we have are anecdotal stories from both patients and doctors that in SOME (not all) instances a generic does not work as well or has additional side effects compared to the brand name. I think we can all agree that a reasonable solution would be to require patients to at least try a generic if one is available. If it works, great! Keep taking it. If it doesn’t, try other manufacturers (including the brand manufacturer if that’s the only other option) until an effective solution is found. But it would be very unfair to penalize people who only get relief from the brand drug just because a trial was never done to prove there was an actual clinical difference between the generic and brand drugs.

I worry more about the endless string of non-superior name-brand alternatives that are continually churned out. My experience is mostly with this phenomenon in proton pump inhibitors. There is absolutely no evidence that one PPI produces better acid suppression, in a clinically important way, than another. Yet patients and families swear by the new stuff. When we prescribe based on a subjective response to a medication (as is nearly always the case), we’re wide open to new, non-superior alternatives that were completely unnecessary to begin with.

Nexium is a classic example. Omeprazole (Prilosec) was the first PPI, and has been in generic for quite some time. Nexium is esomeprazole, which is simply a stereoisomer of omeprazole (which is a racemic mixture of both the active and inactive forms). There is literally nothing chemically different about esomeprazole, it just lets you dose at 1/2 the mg (10 vs. 20 mg, for instance). Yet Nexium has been an enormous success, largely due to marketing, availability of attractive formulations, and a heavy push into new markets, like children less than 1.

I find it interesting that there is not a single comment (so far) suggesting that direct-to-consumer advertising may be implicated in patient requests for brand-name product. “Medicalization, Markets and Consensus”, P. Conrad and V Leiter in the Journal of Health and Social Behavior, 2004, vol 45: 158-176 may be of interest.

aaron, until the FDA can guarantee that generic drugs are equal, 100%, to brand, then i don’t feel we should be forced to take them.

i complained and others complained and we all got sicker and sicker, what does it have to take for these drugs to be the same?

there is a LOT of anecdotal evidence (yes, i know how you feel about this phrase) from patients with seizure disorders and the the doctors that treat them, that changing from brand to generic, generic to different generic, etc, has caused breakthrough seizures. i happen to be on one of those drugs for a mood disorder, and specify which particular generic i will take (and the one i won’t, which brought breakthrough depression).

should we be fooling around with this? shouldn’t these drugs warrant the same testing? because i thought the wellbutrin was the same drug, and the results were devastating

You’re not talking about a drug, you’re talking about a formulation. And I don’t know that the way that the FDA spot checks generics is any different than the way it spot checks brand name drugs. I’m going to ask on twitter.

sorry, i don’t buy it. while no lover of big pharma, i am supporting them far too much, i will lay $$ that there are issues with generic formulations of neurological drugs, but it won’t happen to me this time. learned my lesson. once burned, as they say.

Why are you making a distinction between the drug and the formulation? The formulation is often important in determining the effects of a medication. Changing the formulation may change the effects of the drug. The effects are the only thing that the patient and the doctor care about in the end.

If you want more than anecdotal information, then you are going to have to insist that trials are run on all medications (there goes some of the savings). Otherwise, absence of ideal evidence is not evidence of absence of an effect.

Finally, if generics only have to be within minus 20 to plus 25% of the original, you can’t say there isn’t a difference. I assume that doctors prescribe a dosage for a reason. I don’t recall a plus or minus on most of my prescriptions. It just may not have an effect in most cases.

You’re taking this too far. All I’m saying is there is no reason to believe that a generic is monitored in a different way than a brand name drug. There’s no reason to believe one is “safer” or “more effective”.